Tg Therapeutics, Inc. · NASDAQ:TGTX
Tg Therapeutics — Investor Presentation (September 2013)
24 slides from Tg Therapeutics's investor presentation, Sep 27, 2013
Slide 1: TG Therapeutics
brs ) $ TG Therapeutics NASDAQ: TGTX September 2013
Slide 2: Forward Looking Safe Harbor Statement
This presentation contains forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as “anticipates”, “expects”, “plans”, “believes”, “intends”, and similar words
Slide 3: TG Therapeutics, Inc.
3 ▪ Emerging biopharmaceutical company focused on cancer & autoimmune - related diseases ▪ Formed as a spin - out from LFB Biotechnologies, a French pharmaceutical company in January 2012 ▪ $0.5B sales ▪ Private company, sole shareholder the French government ▪ Developing two drugs for B - cell canc
Slide 4: Evolving market dynamics in treatment of B-cell cancers
4 Today… Treatment of B - cell cancers Evolving market dynamics Treatment Line of Therapy Sales Rituxan 1 st and 2 nd ~$5B Benda mustine 1 st and 2 nd ~$1B CHOP 1 st and 2 nd Nominal Chemotherapy 3 rd and Salvage Nominal Future…non - chemotherapy - based combinations, with: ▪ Anti - CD20’s continuin
Slide 5: Anti-CD20 + Kinase Inhibitor Combination Therapy is the Future
5 Anti - CD20 + Kinase Inhibitor Combination Therapy is the Future
Slide 6: Anti-CD20 Landscape
6 Anti - CD20 Landscape mAb’s Company Attribute Status Rituxan (rituximab) Roche Type 1, Chimeric Approved NHL, CLL, RA, GPA, MPA Arzerra ( Ofatumumab ) Genmab /GSK Type 1, high CDC Approved R/R CLL GA101 ( Obinutuzumab ) Roche Type 2, high ADCC, PCD Phase III (primarily frontline settings) TG - 110
Slide 7: Multiple Pathways for Regulatory Approval
Multiple Pathways for Regulatory Approval 7 TG - 1101 Combo with 1202 in NHL/CLL Combo with Idelalisib in iNHL Priority Clinical Programs Combo with Ibrutinib in MCL and CLL
Slide 8: TG-1101 (ublituximab)
▪ Same target (CD20) as Rituxan ® but NOT a biogeneric or biosimilar ▪ Unique protein sequence ▪ Potential advantages over current standard of care: ▪ Glycoengineered to enhance the cell killing effects of the body’s immune response — (Antibody Dependent Cellular Cytotoxicity) ▪ Demonstrated activit
Slide 9: TG-1101 in the Treatment of Rel/Ref CLL
0 5,000 10,000 15,000 20,000 25,000 30,000 35,000 40,000 45,000 50,000 0 1 2 3 4 5 6 7 8 9 10 11 12 Lymphocytes (109/L) Month 9 Part II Patients 12 Evaluable 11 * CR 0 PR at M4 7 (63.6%) SD at M4 4 PD at M4 0 PR at M6 5 (45.5%) In a pivotal study of rituximab monotherapy in patients with previousl
Slide 10: TG-1101 Phase 1 Efficacy Results in Rel/Ref NHL
o 10 / 12 patients were evaluable for efficacy ( 2 patients were too early for response assessment ) o 5 patients achieved an objective response ( 3 CRs, 2 PRs) 10 90% of evaluable patients had a reduction in target lesion ASCO 2013 Presentation: TG - 1101 Phase 1 Efficacy Results in Rel /Ref NHL
Slide 11: Upcoming Combination Trials
Upcoming Combination Trials 11 ▪ TG - 1101 in Combination with Ibrutinib ▪ Eligibility: CLL and MCL (as per ibrutinib label) ▪ Sites: 20 - 30 Centers ▪ Status : Site review/contracts ▪ Target Start Date: Prior to October 30, 2013; awaiting ibrutinib approval ▪ Lead Centers: USON and Columbia Univers
Slide 12: TGR-1202 (PI3K-δ Inhibitor)
TGR - 1202 (PI3K - δ INHIBITOR) 12
Slide 13: Enzyme Specificity
13 Enzyme Specificity PI3K -2 0 2 4 6 0 20 40 60 80 100 120 IC50 22.23 Log Conc (nM) % inhibition Fold - selectivity Isoform α β γ δ TGR - 1202 >10000 >50 >48 1 1 Idelalisib >300 >200 >40 1 2 IPI - 145 >640 >34 >11 1 1 Flinn et al. 2009, 2 Porter et al. 2012
Slide 14: TGR-1202 vs. Idelalisib
TGR - 1202 vs. Idelalisib 14 Friedman et al 2012, ASH Poster ▪ Blinded in vitro study conducted at Duke University comparing TGR - 1202 and Idelalisib in CLL patient cells (n=7) Equivalent dose dependent cytotoxicity Equivalent suppression of pAKT Equivalent dose dependent induction of apoptosis
Slide 15: Structural Comparisons
Structural Comparisons ▪ Idelalisib and IPI - 145 structure displays very high similarity (over 80% homologous ) and contain nitrogen based heterocyclic backbones known to interact with hepatic enzymes ▪ TGR - 1202 structure (not yet disclosed) has different backbone designed to potentially minimize
Slide 16: Pre-Clinical Pharmacokinetics
Pre - Clinical Pharmacokinetics of TGR - 1202 16 TGTX/ Rhizen Internal Data Parameter Units Mice Rat Dog Monkey Dose mg/kg 20 20 30 50 C max µM 7.81 6.08 4.21 2.68 AUC 0 - t µM.hr 33.96 59.41 94.86 29.29 AUC 0 - inf µM.hr 34.02 105.01 172.65 30.73 T max hr 0.50 1.50 7.00 3.00 t ½ hr 2.39 17.85 37.13
Slide 17: Phase I First-in-Human Study
17 Phase I First - in - Human Study of TGR - 1202 Patients with Rel /Ref Hematologic Malignancies ▪ Includes Patients with Relapsed/Refractory Hematologic Malignancies ▪ No limit on prior therapies ▪ Continuous once daily oral dose (QD) Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7
Slide 18: Preliminary Human Pharmacokinetics
18 0.00 400.00 800.00 1200.00 1600.00 2000.00 Concentration (ng/mL) TGR - 1202: Preliminary Human Pharmacokinetics 50 mg 100 mg 200 mg 400 mg 800 mg Cycle 1, Day 15 Trough Plasma Concentrations ▪ TGR - 1202 is rapidly absorbed with a linear PK profile through 800 mg QD (highest dose administered to
Slide 19: Preliminary Human Pharmacokinetics: Plasma Concentration Projections
0 1 2 3 4 5 6 7 Concentration ( uM ) 19 TGR - 1202: Preliminary Human Pharmacokinetics 800 mg Actual 1200 mg Projected 1800 mg Projected Day 15 Plasma Concentration Projections Assuming Linear PK 1 Idelalisib 150 mg BID C max 2 IPI - 145 25 mg BID C max ▪ Plasma concentrations approaching bottom end
Slide 20: Preliminary Findings
20 TGR - 1202: Preliminary Findings ▪ Extended half - life supports 1x daily dosing ▪ Linear PK through 800mg qd ▪ Only one DLT observed: Gr. 3 rash at 800mg possibly related to study drug ▪ Rash resolved and patient restarted without recurrence ▪ No drug related hepatotoxicity observed to date ▪ Si
Slide 21: Upcoming Milestones
21 Upcoming Milestones Commence TG - 1101 plus Ibrutinib combo trial Commence TG - 1101 plus TGR - 1202 combo trial Present preliminary safety and efficacy of TGR - 1202 Present preliminary data from combo trials Commence combination registration trials Present additional Ph. 1/2 single agent TG - 1
Slide 22: Corporate & Financial
22 Corporate & Financial TGTX ( NasdaqCM ) $6.15 ~$51M (pro forma June 30, 2013, including July capital raise) $2 - $3M per quarter 30 - 36 months of cash ~33M (Primary); ~39M (fully - diluted) Key Statistics Ticker: Price: Shares: Cash: Burn: Time:
Slide 23: Key Takeaways
23 Key Takeaways ▪ Unequivocal activity of TG - 1101 in CLL and NHL ▪ Positioning TG - 1101 as the backbone of combination therapy in Rituxan ® relapsed/refractory patients, a multi - billion dollar opportunity ▪ Multiple combination regulatory pathways for TG - 1101 ▪ Novel PI3K Delta inhibitor wit
Slide 24: TG Therapeutics
) £ TG Therapeutics NASDAQ: TGTX
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